Polycystic Ovary Disease (PCOS) is the most common endocrine disorder among reproductive age women, and is the most common cause of irregular cycles and anovulatory infertility. Acupuncture may represent an alternative to hormonal treatment for these women, based on three studies with positive findings with fewer than 50 acupuncture subjects and no control group. The best of these studies examined 24 PCOS women and found that 38% of the women had restored ovulation (2+ ovulations) during the treatment plus follow-up time period. The proposed research will be a double-blind, placebo-controlled, randomized clinical trial to assess if acupuncture restores ovulation (2+ ovulations) and normalizes ovarian hormones in women v/ith PCOS. Participants (n=78 completers) will be randomized to receive either acupuncture treatment or a sham procedure (Park Sham Device) for a standard 8-week period of time. All participants will provide blood samples through the University of Virginia General Clinical Research Center before treatment, after treatment, and three months later from which reproductive hormones, androgens and insulin/glucose will be assayed. Urine samples will be provided weekly throughout the treatment and follow-up periods to determine if ovulation has occurred. To collect data on potential confounders, weight will be measured and questionnaires administered at the same three time periods as the blood samples. Results will be analyzed with a combination of odds ratios, multiple logistic regression, repeated measures analyses, generalized estimating equations, and analysis of covariance. This study will be a clear enhancement compared to the existing literature by inclusion of a sham treatment control group, rigorous diagnosis of PCOS, and collection of blood samples timed to the menstrual cycle (applicable when there is an ovulatory cycle). This research will assess within our PCOS population whether acupuncture increases ovulatory frequency, causes the ratio of follicle simulating hormone (FSH) to luteinizing hormone (LH) to normalize, and causes the mean levels of FSH and LH to adjust towards normal levels (increase and decrease, respectively). Toward future research, an exploratory analysis will also be conducted to estimate if some patient groups (e.g., normal insulin, smaller body mass index) are more responsive to acupuncture therapy. We will also compare enrollment strategies for population-based recruitment of women into an acupuncture clinical trial. ? ?

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21AT002520-03
Application #
7274714
Study Section
Special Emphasis Panel (ZAT1-JH (07))
Program Officer
Caldwell, Sheila
Project Start
2005-09-15
Project End
2010-08-31
Budget Start
2007-09-01
Budget End
2010-08-31
Support Year
3
Fiscal Year
2007
Total Cost
$148,916
Indirect Cost
Name
University of Virginia
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904
Thompson, M E; Jenkins, J; Smucker, A et al. (2012) Acupuncturist perceptions of serving as a clinical trial practitioner. Complement Ther Med 20:183-9
Stovall, Dale W; Scriver, Jessica L; Clayton, Anita H et al. (2012) Sexual function in women with polycystic ovary syndrome. J Sex Med 9:224-30
Franasiak, Jason; Young, Steven L; Williams, Christopher D et al. (2012) Longitudinal anti-müllerian hormone in women with polycystic ovary syndrome: an acupuncture randomized clinical trial. Evid Based Complement Alternat Med 2012:973712
Pastore, Lisa M; Patrie, James T; Morris, Wendy L et al. (2011) Depression symptoms and body dissatisfaction association among polycystic ovary syndrome women. J Psychosom Res 71:270-6
Stovall, Dale William; Bailey, Amelia Purser; Pastore, Lisa M (2011) Assessment of insulin resistance and impaired glucose tolerance in lean women with polycystic ovary syndrome. J Womens Health (Larchmt) 20:37-43
Pastore, Lisa M; Williams, Christopher D; Jenkins, Jeffrey et al. (2011) True and sham acupuncture produced similar frequency of ovulation and improved LH to FSH ratios in women with polycystic ovary syndrome. J Clin Endocrinol Metab 96:3143-50
Pastore, Lisa M; Dalal, Parchayi (2009) Recruitment strategies for an acupuncture randomized clinical trial of reproductive age women. Complement Ther Med 17:229-35